Mencevax ACWY

SmithKline Beecham International - Pharmaceuticals

[CPI Manufacturer]

Permitted in sport

Pregnancy Category B2

Use: Active immunisation against meningococcal meningitis (groups A, C, W[135], Y) in adults, children > 2 years: close contacts of patients with disease; travellers to epidemic countries; epidemic control in confined communities

Contraindications: Severe acute febrile illness; IV admin.

Precautions: Impaired immune response; acute malaria; pregnancy, lactation Adverse Reactions: Local erythema, induration, pain; lymphadenopathy; fever; URT illness; malaise; headache; increased meningococcal carriage rates

 

Mencevax ACWY (Injection) Rx

Neisseria meningitidis vaccine

Neisseria meningitidis (meningococcus) groups A 50 mcg, C 50 mcg, W[135] 50 mcg and Y 50 mcg (purified polysaccharides) per 0.5 mL; lyophilised; monodose vial; Gluten free.

Pack(s): 0.5 mL (+ solv.) .Fields[1]: $43.55

Dose: Adults, children > 2 years: 0.5 mL SCI; see MIMS

Annual

 

Composition

Active.

Each 0.5 mL dose of reconstituted vaccine contains 50

microgram of each of the polysaccharide of groups A, C,

W[135] and Y.

 

Inactive.

Solvent: isotonic sodium chloride solution.

 

Description

Mencevax ACWY is a lyophilised preparation of purified polysaccharides from Neisseria meningitidis (meningococcus) of groups A, C, W[135] and Y. It is presented as a white pellet in a glass vial together with a separate vial of clear, colourless, sterile saline solvent. When reconstituted with the solvent supplied, the vaccine is ready for subcutaneous injection.

 

Actions

A single 0.5 mL dose of Mencevax ACWY elicits a significant antibody response against each of group A and group C meningococci in over 90% of adolescents and young adults, lasting at least 12 months.

 

Responses to W[135] and Y meningococci appear to be equally good, but have been less well studied. Fewer data are available on response rates in children 2 to 13 years, and antibody persistence may be shortened, especially in the two to four year age group.

 

Although the clinical efficacy of the A or C components of the vaccine has been demonstrated, there are currently no data available on the protective efficacy of the antibody response to group W[135] and Y polysaccharides.

 

Indications

Active immunisation against meningococcal meningitis caused by group A, group C, group W[135] and group Y meningococci in adults and children over two years.

 

The vaccine may be used for subjects who are close contacts of patients with disease caused by meningococci of groups A, C, W[135] and Y; for travellers to countries where the disease is endemic or highly epidemic; and for controlling epidemics of infection caused by groups A, C, W[135] and Y meningococci in confined communities.

 

Mencevax ACWY is not recommended for use in infants and children under two years of age as antigenicity of the vaccine is low in this age group and antibodies persist for shorter duration.

 

Contraindications

As with all vaccines, Mencevax ACWY is contraindicated in subjects with severe acute febrile illnesses. However, the presence of a trivial infection does not contraindicate vaccination.

 

The multidose presentations should not be used in subjects with known systemic hypersensitivity to phenol.

 

Warnings

The vaccine gives no protection against meningococcal meningitis caused by meningococci belonging to groups other than A, C, W[135] and Y.

 

If administered to subjects with impaired immune responses, the vaccine may not induce an effective response.

 

Immune response to the vaccine may be impaired after acute malaria.

 

The use of Mencevax ACWY may increase the meningococcal carriage rates, especially for meningococcal groups not included in the vaccine.

 

Precautions

Mencevax ACWY is for subcutaneous use only: do not

administer intravenously.

 

Appropriate precautions should be taken to prevent the transmission of any infectious agent.

 

No information is available concerning the effects of drugs, intercurrent illnesses or other vaccines on the response to the administration of Mencevax ACWY.

 

As with all injectable vaccines, a solution of adrenaline 1 in 1,000 should always be readily available for immediate injection in case of rare anaphylactic reactions. For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.

 

Use in pregnancy.

(Category B2)

 

There is no convincing evidence of risk to the fetus from immunisation of pregnant women using an inactivated bacterial vaccine. However, there are no studies on the effect of the purified polysaccharides contained in Mencevax ACWY on the fetus. Therefore, the vaccine should not be given to pregnant women unless the benefits to the mother clearly outweigh any risks to the fetus.

 

Use in lactation.

No information is available on the safety of the use of Mencevax ACWY during lactation.

 

Adverse Reactions

Mencevax ACWY may induce local and systemic reactions;

local reactions occur in the majority of adults and include erythema, induration, tenderness or pain at the site of injection and local axillary lymphadenopathy. Febrile reactions (> 38 deg.

C) and chills, which are less common, may appear within hours of vaccination and may persist for 24 to 48 hours or longer. Upper respiratory tract illness, headache and malaise occur occasionally. A transient local immediate weal and flare reaction and hypersensitivity reactions including anaphylactoid reactions may occur rarely. Local and systemic adverse reactions, especially febrile reactions, may be encountered more frequently in children than in adults.

 

Dosage and Administration

Mencevax ACWY should be reconstituted only with the saline solvent supplied by adding the entire contents of the supplied vial of solvent to the vaccine vial. The reconstituted vaccine should be inspected for any foreign particulate matter and/or colouration prior to administration. In the event of either being observed, discard the vaccine.

 

The reconstituted vaccine should be administered subcutaneously with a sterile syringe and needle. One dose of vaccine is contained in 0.5 mL.

 

Data on the persistence of antibody response are limited and the optimal time for revaccination is not known at present. It appears likely that the antibody response will last for at least one year, possibly longer.

 

Presentation

Vials, with sterile saline as solvent: monodose.

 

Storage

Store lyophilised vaccine in a refrigerator at 2 to 8 deg. C or in a freezer. Shelf life: 2 years.

 

The solvent can be stored at ambient temperatures.

 

After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If it is not used within eight hours, it should be discarded because of the risk of contamination.

 

It is recommended to protect the reconstituted vaccine from direct sunlight.

 

When supplies of Mencevax ACWY are distributed from a

central cold store, it is good practice to arrange transport under refrigerated conditions, particularly in hot climates.

 

Poisons Schedule

S4.

----- Original Message -----

From: "Sheri Nakken" <vaccineinfo@btinternet.com>

To: <i-v-y@yahoogroups.com>; <avml@topica.com>; <AVN@yahoogroups.com>; <immunizations@egroups.com>; <vaccineinfo@yahoogroups.com>; <vaccinations@yahoogroups.com>

Sent: Wednesday, March 06, 2002 3:58 PM

Subject: [i-v-y] Re: [AVN] Meningococcal vaccine - help please?

 

 

At 08:58 AM 03/06/2002 +1100, you wrote:

>I have had a mother ask me about the ingredients and documented adverse

>effects for this particular vaccine. Does anyone have access to a

>product insert?

>

>Thanks,

>Bronwyn

 

Is it the Wyeth one

 

http://www.doh.gov.uk/meningitis-vaccine/keypharm.htm

Wyeth one in UK (& Chiron one)

 

USE OF MENINGOCOCCAL GROUP C CONJUGATE VACCINE

 

KEY PHARMACEUTICAL/TECHNICAL ISSUES

(UPDATED AUGUST 2000)

Q1: What are the details of presentations and pack sizes?

 

A:  The vaccine is available in the following presentations:

 

1.Wyeth Vaccines (Brand name: Meningitec): A single pack containing 1 x 1 dose in glass vial (0.5ml suspension) and a multipack containing 10 x 1 dose in glass vials (0.5ml suspension).

 

The dimensions are:

 

 

(1 x 1 dose pack) 36 mm long x 25 mm deep x 52 mm high

(10 x 1 dose pack)  76 mm long x 52 mm deep x 45 mm high

 

The product is not shrink-wrapped.

 

2. Chiron Vaccines (Brand name: Menjugate): A single pack containing 1 x 1 dose glass vial of lyophilised powder and a glass vial containing 0.5ml diluent for reconstitution. There is also a single pack containing 1 x 10 dose glass vial of lyophilised powder and 1 glass vial of diluent.

 

The dimensions are:

 

 

(1 x 1 dose pack)  141 mm long x 41 mm deep x 22 mm high

(1 x 10 dose pack)  56 mm long x 36 mm deep x 70 mm high (shrink wrapped in outers of 5)

 

3. North American Vaccine (Brand name: NeisVac-C): A multipack containing 20 x 1 dose in pre-filled syringes (0.5ml liquid suspension) without needle.

 

 

The dimensions are: 223 mm long x 107 mm deep x 52 mm high.

 

The product is not shrink-wrapped.

 

The Wyeth brand is licensed for use in children and older people of any age and is being supplied through primary care in a single dose presentation.

 

The Chiron brand is currently licensed only for use in children over 12 months of age and the initial supply is mostly in a multi dose presentation and will be used only in the schools programme.

 

 

The North American Vaccine brand is currently licensed only for use in children over 12 months of age and is in a single dose syringe presentation and the initial supply will be used only in the schools programme.

 

We are advised that the marketing authorisation holder, North American Vaccine (UK) Ltd has recently been acquired by Baxter Healthcare Ltd. Further information is available from the Hyland Immuno division of Baxter Healthcare Ltd.

 

Q2:  Is there an overage in the presentations?

 

A:  There is adequate vaccine in each presentation to provide at least the full quantity of recommended dose/doses.

 

Q3:  Will the vaccines need to be transported under cold chain conditions?

 

A:  The meningococcal group C conjugate vaccine should be stored at temperatures of 2o -8oC at all times. It should be discarded if frozen, or if it is suspected to have been exposed to temperatures less than 2oC. In addition it should be kept away from sources of direct heat, such as a radiator and out of direct sunlight.

 

When the vaccine is transported to, and used in a school, it may not always be practical to keep it stored between temperatures of 2o-8oC.

 

For the Wyeth product we have data to suggest that the stability of the vaccine will not be impaired if it is kept at temperatures not exceeding 25oC for no longer than 24 hours.

 

On the basis of the above data, we would advise that for the Wyeth product, unrefrigerated vaccine does not have to be discarded on the day of issue but can be returned to appropriate refrigeration provided that:

 

Vaccine stored outside of the 2o-8oC recommended range is appropriately marked before being returned to refrigeration to ensure that when next issued it is used on that occasion.

 

 

Vaccine is only subjected to re-refrigeration on one occasion.

 

 

Total exposure time to temperatures between 8o and 25oC does not exceed 24 hours. For the Chiron product we have data which demonstrates that the lyophilised vaccine is stable when held for 3 months at 30oC, after storage at 2o-8oC for 18 months. The diluent is stable for 18 months at 30oC.

 

On the basis of the above data for the Chiron product we would advise that unrefrigerated vaccine does not have to be discarded on the day of issue but can be returned to appropriate refrigeration provided that:

 

Vaccine stored outside of the 2o-8oC recommended range is appropriately marked before being returned to refrigeration to ensure that when next issued it is used on that occasion.

 

 

Total exposure time of the vaccine to temperatures between 8oC and 30oC does not exceed 3 months. The Department of Health is advising that any multi-dose vaccine once reconstituted should be used within 4 hours.

 

For the North American Vaccine product we have data to suggest that the stability of the vaccine will not be impaired if it is kept at temperatures not exceeding 40oC for no longer than 30 days.

 

On the basis of the above data for the NAVA product we would advise that unrefrigerated vaccine does not have to be discarded on the day of issue but can be returned to appropriate refrigeration provided that:

 

Vaccine stored outside of the 2o-8oC recommended range is appropriately marked before being returned to refrigeration to ensure that when next issued it is used on that occasion.

 

 

Total exposure time of the vaccine to temperatures between 8oC and 40oC does not exceed 30 days.

Q4: What is the shelf life of the vaccine?

 

A:  The Wyeth and Chiron vaccines have a shelf life of 18 months.

 

The North American Vaccine product has a shelf life of 12 months.

 

Q5:  What are the possible side effects? eg headaches

 

A:  Meningococcal Group C conjugate vaccines are well tolerated in all age groups. The rates of local reactions and systemic reactions are similar to those seen previously with Hib vaccines. Further information is available in the CMO Update 27 (August 2000), the joint CMO/CNO/CPhO Letter (PL/CMO/99/4, PL/CNO/99/8,PL/CPHO/99/3 issued in October 1999), the replacement chapter on Meningococcal Group C conjugate vaccine for "Immunisation against Infectious Disease 1996", the leaflet 'Reduce the

risk: Your guide to the new meningitis vaccine' and in the Fact Sheet for health professionals on Meningitis C conjugate vaccine.

 

The following side effects sometimes happen one to three days after immunisation in the age groups shown below.

 

 

Babies Some redness or swelling where the injection was given. One in two babies may become irritable. One in 20 babies may have a mild fever.

 

Toddlers

(over 12 months)

 Some redness or swelling where the injection was given.

One in five toddlers may become irritable.

One in 20 toddlers may have a mild fever.

 

Pre-school children

 One in 10 children may have redness or swelling where the injection was given. About one in 100 children may have a mild fever. One in 25 children may become irritable.

 

Children and

young people

 About one in three may have some redness or swelling where the injection was given and one in 100 may have a very sore arm from the injection which may last a day or so. About one in 50 may have a mild fever. About one in 20 primary school children and one in seven secondary school children may have a headache.

 

 

These side effects also occur at similar levels after other routine immunisations given to babies, children and young people.

 

Following injections some young people may experience nausea, vomiting, minor skin rashes, dizziness and tiredness and some young people may faint at the time of the injection.

 

There have been very rare reports of people having fits: these have usually been febrile or associated with fainting and recovery has usually been very quick. Fits have not been shown to be caused by the vaccine.

 

Q6:  How should any suspected adverse reactions be reported?

 

A:  As this vaccine is a new product, it carries a 'black triangle' symbol.

 

If a doctor or pharmacist suspects any adverse reaction (ADRs) to the vaccine, however minor, he/she should report this to the Medicines Control Agency through the Yellow Card spontaneous reporting scheme in the normal manner.

 

Reports of suspected ADRs will now be accepted by MCA directly from nursing staff who are involved in administering the vaccine or involved in the care of individuals receiving the vaccine, for the period of the meningitis vaccine campaign. Nursing staff should complete and sign the Yellow Card and include the doctor's name and address. When including the name and address of the doctor the nurse does not need to obtain the doctor's signature.

 

As there are now three suppliers of the vaccine it is important to identify both the brand and the batch number of the vaccine when reporting an adverse reaction.

 

Q7:  Does the vaccine contain thiomersal, human albumin, bovine components or human fetal material?

 

A:  Manufacturers have been asked for answers to these points.

 

According to Wyeth, one of the components used in the manufacture of the vaccine is derived from cow's milk but no bovine material is added to the final product. The milk-derived components used in the production of the vaccine comes from countries where no BSE has ever been reported. The vaccine does not contain any thiomersal, human albumin or human fetal material.

 

Chiron have stated that one of the components used in the manufacture of the vaccine is derived from cow's milk but no bovine material is added to the final product. The milk-derived component used in the production of the vaccine comes from countries where no BSE has ever been reported (Australia and/or New Zealand). The finished product does not contain thiomersal, human albumin or human fetal material.

 

North American Vaccine has confirmed that the finished product does not contain thiomersal, human albumin or human fetal material. Semi-solid special agar containing beef broth is used for the initial propagation of the Clostridium tetani seed cultures prior to inoculation of the fermentor. No bovine material used in the early stages of the production is present in the final product. A component derived from cow's milk is also used in the vaccine manufacture, but not added to the final product.

 

Bovine materials used in production comply with the European CPMP recommendations and are sourced from 'BSE-free' countries according to the current criteria.

 

Q8:  Is the vaccine genetically modified?

 

A:  Two of the vaccines are manufactured using a natural genetic variant as a carrier protein.

 

This component has been used for many years in other vaccines.

 

Q9:  Are the different brands of Meningitis C vaccine interchangeable?

 

A:  The new meningococcal C vaccines use the same technology as that applied to the development of Hib conjugate vaccines. Experience from the use of Hib vaccines suggests that different brands of the Meningitis C vaccine are interchangeable.

 

Q10: Can this vaccine be given with other vaccines including travel vaccines?

 

A:  As we have advised in the DH fact sheet for health professionals on Meningitis C vaccine, studies have shown that this vaccine can be safely given with routine childhood immunisations including DTP/Hib, MMR, DT, Td, oral polio vaccine and IPV.

 

There are no studies to date on hepatitis B or BCG vaccine being given at the same time although there is no reason to suspect an interaction. BCG vaccine has been given within a month of meningococcal C conjugate vaccine with no adverse effects.

 

Travel vaccines other than the meningococcal plain polysaccharide A and C vaccine can be given at the same time as the meningococcal C conjugate vaccine but as with other vaccines, it is preferable to administer them at different sites.

 

Q11: Should the meningococcal C conjugate vaccine be given to patients who have received the meningococcal plain polysaccharide A and C vaccine in the past?

 

A: A gap of six months is suggested between the administration of the meningococcal plain polysaccharide A and C vaccine and the subsequent meningococcal C conjugate vaccine except in conditions of very high risk in young children (under five years of age) who would not be expected to have responded well to the earlier administration of the C component of the polysaccharide vaccine. Such children may receive the meningococcal C conjugate vaccine at least two weeks after the plain polysaccharide A and C vaccine.

 

Q12: How long after the administration of the meningococcal C conjugate vaccine can the meningococcal plain polysaccharide A and C vaccine be given?

 

A: A minimum of two weeks should be left after the administration of the meningococcal C conjugate vaccine before the meningococcal plain polysaccharide A and C vaccine is given.

 

Q13:  Can the new meningococcal vaccine be given for travel purposes?

 

A:  Meningococcal plain polysaccharide A & C vaccine (ACVax or Mengivac A +

C) is still recommended for people travelling to high risk countries. Vaccine required for travel immunisation must be ordered from the manufacturers in the usual way.

 

Q14:  What advice do we give if asked about interactions between the vaccine and drinking alcohol and the use of illicit drugs?

 

A:  There are no known interactions with consumption of alcohol. We have no information on any interactions between meningococcal C vaccine and illicit drugs.

 

Q15: Are there adequate patient information leaflets supplied with multidose presentations?

 

A.  We understand that there are adequate patient information leaflets for each dose of vaccine.

 

Q16: How are consumables supplied?

 

A:  Consumables such as needles, syringes and 'sharps' bins are obtained locally and distributed through the normal channels.

 

Q17: Are anaphylactic packs available?

 

A:  These are provided locally as for any routine immunisations.

 

The advice on the management of anaphylaxis provided in 'Immunisation against Infectious Disease 1996' remains current.

 

Q18: What funding is available?

 

A:  Resources are allocated to Health Authorities, according to the school aged target population, through a Cash Limit Adjustment. Across all English Health Authorities a total of £1.8m last year and around £6.5m this financial year has been allocated. This represents an allocation of £1 per child aged 5 to 17 years and is used to support the schools' programme. Trusts will need to contact Health Authorities to see how the money is allocated within Health Authorities.

 

Q19: How is the input of pharmacy services to this campaign supported?

 

A:  Trust Chief Pharmacists negotiate with Health Authorities/Trusts to ensure that the programme is appropriately resourced.

 

Details of the additional activities which need to be resourced were given in the joint professional letter from

CMO/CNO/CPhO(PL/CMO/99/2,PL/CNO/99/4,PL/CPHO/99/1) dated 20 July 1999.

 

Further information

 

For details of other questions which have been asked it would be best to contact your local Drug Information Pharmacist.

 

There is a factsheet on meningococcal C vaccine as part of the HEA - now Health Promotion England - series for health professionals. This was sent directly to all health professionals on the HEA/HPE database. There is also available a parent information leaflet 'Meningitis C Reduce the Risk. Your guide to the new meningitis C vaccine' available through local suppliers or from Health Promotion England. Details can be found on the HEA/HPE website at www.immunisation.org.uk.

 

This Q and A is available on the Department of Health website at: http://www.doh.gov.uk/meningitis-vaccine.htm.

 

DEPARTMENT OF HEALTH

AUGUST 2000